Saturday, 23 January 2016

Borderlines between medical devices and medicinal products

What
is the difference between a medical device and a medicinal product? The
definitions are often blurred.

To
help to interpret this, the U.K. MHRA have a document that sets out, in broad
terms, the regulation of specific products and distinguishes those which are
regulated as medical devices and those which are regulated as medicinal
products, particularly where the regulation may be on the borderline between
the two sets of regulations.

Whilst
there are other ‘borderlines’ with medical devices (for example with cosmetics,
personal protective equipment, biocides etc) this document relates specifically
to the differentiation between medical devices and medicinal products.